Lymph Node Metastases, Sentinel Lymph Node, Thyroid Cancer, Thyroid Carcinoma, Papillary, Thyroid Metastases, Thyroid Neoplasms
Conditions
Keywords
Near-infrared (NIR) fluorescence, Total thyroidectomy, Parathyroid glands, Indocyanine green (ICG), Central lymph node dissection
Brief summary
Indocyanine green (ICG) is a water-soluble organic dye that is cleared totally through the hepatobiliary system. It has a half-life of 3-4 mins, which allows repeated applications. Near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) imaging has been recently introduced, and has been suggested as a useful tool for the identification and preservation of the parathyroid glands (PGs) during total thyroidectomy (TT). ICG can also be used for sentinel lymph node (SLN) biopsy to predict the micrometastases in central lymph nodes (CLN) in thyroid carcinoma, and central lymph node dissection can reduce local recurrence.
Detailed description
Incidence of thyroid cancer has doubled between 1980 and 2020, and it is now the fifth most common malignant tumor among women. The majority are papillary thyroid cancer (PTC), and TT is the procedure of choice. Since the micrometastasis rate of the central lymph nodes (CLNs) is about 30% to 90% in PTC, CLN dissection can improve the prognosis and reduce tumor recurrence as well as provide accurate information for the evaluation of tumor staging. However, TT procedure has some important complications such as vocal cord paralysis (VCP) and hypocalcemia (due to accicental parathyroidectomy or damage to the parathyroid gland-PG- vasculature). Use of intraoperative nerve monitoring (IONM) has reduced the rate of VCP. However, the incidence of postoperative hypocalcemia is still high (15-70%), and it is now the most common complication of TT. Intraoperative identification of SLNs and PGs can help surgeon to overcome these problems.
Interventions
PROCEDURETotal thyroidectomy (TT)
Standard TT procedure for thyroid carcinoma, for both groups
PROCEDURECentral lymph node dissection (CLND)
Standard CLND for thyroid carcinoma, for both groups
DIAGNOSTIC_TESTSentinel lymph node (SLN) bopsy
Intrathyroidal injection of ICG for SL biopsy, for only experimental group
DIAGNOSTIC_TESTIdentification of parathyroid glands (PGs)
Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group
Sponsors
Umraniye Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Thyroid carcinoma patients (biopsy/cytology-proven) suitable for total thyroidectomy procedure * Patients at or over 17 years
Exclusion criteria
* Previous thyroid surgery * Patients below 17 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Involvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion | 1 year | Intrathyroidal injection of indocyanine green (ICG) dye to identify sentinel lymph node (SLN) for biopsy |
| Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast | 1 year | İntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central lymph node dissetion (CLND) | 1 year | Number of positive lymph nodes (micrometastases) |
Countries
Turkey (Türkiye)
Contacts
Primary ContactEthem Unal, MD, PhD, USMLE&IFSO-CSS, A. Prof.
Backup ContactSema Yuksekdag, MD
Outcome results
None listed